Propolisol

Patient Information Leaflet

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Read the entire leaflet carefully, as it contains important information for the patient.
This medication is available without a prescription to treat certain conditions without a doctor's assistance. However, to achieve good treatment results, the medication
Propolisol should be used carefully and in accordance with the information
in the leaflet.

• Keep this leaflet to read again if needed,
• Consult a doctor or pharmacist if advice or additional information is required,
• If symptoms worsen or do not improve after using the preparation, consult a doctor,

Propolisol

Propolis extract, 25mg/ml
Spray solution for skin application
Composition
100 ml of the product contains 100 ml of 3% propolis extract (Propolis extractum 3%)
1 ml of the solution contains 25 mg of propolis.
The medication contains at least 90% (v/v) ethanol.
It does not contain excipients.
Table of contents of the leaflet:

• 1. What is Propolisol and what is it used for?
• 2. Before using Propolisol
• 3. How to use Propolisol?
• 4. Possible side effects
• 5. Storage of Propolisol
• 6. Other necessary information about Propolisol

1. What is Propolisol and what is it used for?

The active ingredient of the preparation - propolis extract is an ethanolic extract of bee glue - propolis. Propolis is a complex substance containing over 300 identified chemical compounds. Among the biologically active components, the most numerous group consists of phenolic compounds (50-60%), including flavonoids (about 5%). The constant representatives of phenolic compounds include benzoic acid, cinnamic acid, coffee acid, and ferulic acid, benzyl alcohol and cinnamyl alcohol, and esters of these compounds. The most common flavonoids include chrysin, tectochrysin, acacetin, apigenin, galangin, kaempferol, quercetin, pinostrobin, and pinochembrin.
In the propolis extract, terpenic compounds (about 1%) also occur in small amounts, mainly geraniol and borneol.

Product intended for traditional use in the indicated indications and its effectiveness is based solely on a long period of use and experience.

The indication for the use of Propolisol is inflammatory skin conditions, cuts, minor skin damage, first-degree burns, and supportive treatment for minor frostbite and bedsores.

2. Before using Propolisol

Do not use in case of allergy to bee products.
Do not use on open wounds.
Do not use in people who are hypersensitive, prone to allergic reactions to various types of allergenic substances (especially preservatives such as benzoic acid, salts, and esters of p-hydroxybenzoic acid).
Exercise particular caution when using Propolisolin people prone to allergies.

In people allergic to other bee products (honey, pollen, royal jelly), the following may occur: rash, redness, swelling, or other symptoms of allergy. In such cases,

discontinue use of the medication.Before starting treatment with propolis, it is recommended to perform an allergy test, which involves applying a small amount of Propolisol liquid to the elbow crease. If swelling, redness, and itching of the skin occur within 3-24 hours, discontinue use of propolis preparations.
Warning: The medication contains 93% ethanol. Frequent external use can cause skin irritation and dryness.

Particular caution in certain groups using Propolisol

Using Propolisol in children:Due to the lack of sufficient data, it is not recommended to use the medication in children under 6 years of age.

Fertility, pregnancy, and lactation

Well-controlled studies of the preparation in pregnant and breastfeeding women have not been conducted, therefore, it is not recommended to use the preparation without consulting a doctor.
Do not use in women with a tendency to allergies.

Driving and operating machinery

No data available

Using other medications

In the case of using Propolisol on a doctor's prescription, inform about all recently taken medications, even those available without a prescription.

3. How to use Propolisol?

Proper use of Propolisol

Propolisol should be used according to the instructions below or as directed by a doctor. If the doctor does not recommend otherwise, it is recommended to use the medication as follows:
Adults, adolescents, and children over 6 years old:locally on the skin, spray 2-4 times a day
1 dose of the spray contains 0.14 ml of the solution.
If you feel that the effect of Propolisol is too strong or too weak, consult a doctor.

Using a higher dose of Propolisol than recommended

No data available regarding overdose .

Missing a dose of Propolisol

If a dose is missed, use it as soon as possible. However, if it is close to the time of the next dose, use the next scheduled dose. Do not increase the dose on your own. Do not use a double dose to make up for a missed dose.

Discontinuing use of Propolisol

In case of doubts regarding the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like any medication, Propolisol can cause side effects, although they may not occur in everyone.

To date, in the course of spontaneous monitoring, no side effects have been reported after using Propolisol.

If any of the following symptoms occur, discontinue use of the medication, inform a doctor, or go to the nearest hospital:

Stop using the medication and consult a doctor or go to the hospital immediately:swelling of hands, feet, face, lips, mouth, throat causing difficulty swallowing or breathing. These are severe side effects, and if they occur, it may indicate the possibility of an allergic reaction (hypersensitivity) to Propolisol. The occurrence of severe side effects may require immediate medical attention and hospital treatment. Severe side effects occur rarely (≥1/10 000 to <1>In people allergic to other bee products (honey, pollen, royal jelly), the following may occur: rash, redness, increased swelling, or other symptoms of allergy. In such cases, discontinue use of the medication. If other side effects occur that are not listed in this leaflet, inform a doctor.
Reporting side effects
If any side effects occur, including those not listed in the leaflet, inform a doctor or pharmacist,
or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
{current address, phone number, and fax of the aforementioned Department}
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medication.

5. Storage of Propolisol

Store the medication in a place inaccessible and invisible to children.
Do not use after the expiration date stated on the packaging.
Store the medication at a temperature below 25°C.
At temperatures below 15°C, a flocculent suspension or sediment may appear (precipitation of lipid components, plant waxes), which does not constitute a product defect. The solution becomes clear when heated above 18°C.

6. Other information

Marketing authorization holder and manufacturer

Marketing authorization holder:
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
Manufacturer:
Farmina sp. z o.o., Myślenice Plant
ul. Cegielskiego 2
32-400 Myślenice
Date of leaflet preparation: 31.07.2017